Next up we have Initiator Pharma and CEO Claus Elsborg Olesen, and we will also be doing an interview.
We'll try that, yeah.
Because I like routines, I will start with the same question to you. If you could just briefly introduce Initiator Pharma and your mission.
Initiator Pharma is a clinical-stage company dedicated to developing transformative treatments within sexual dysfunctions and pain.
How does your lead candidate fit into the mission of helping people with these conditions?
Yeah, so our lead candidate, pudafensine, is a very unique candidate. It actually acts on the central nervous system, so we can modulate responses in the central nervous system, and it's very safe. It's a safe drug that has shown in preclinical and clinical trials that actually has good efficacy across both sexual dysfunction but also pain.
Is that one of the ways that it stands out if you compare to competitors or other alternatives on the market?
Yeah, if you look at the competitors, I need to split it up into a few different groups here, and of course, for the sexual dysfunctions, you can say that the drugs that are currently marketed are working in the periphery, so they can prolong something. They can prolong an erection, or they can prolong increased blood flow to the genitals. Whereas you can say our compound actually goes into the central nervous system, and it actually strengthens the natural erection responses or sexual responses, so thereby you can say that we actually strengthen what's already there, but we're working on the central nervous system of that.
Looking at the pain setting, we are different in the way that monoamines have for many years been a way to modulate pain, but you primarily had to focus on what's called serotonin and noradrenaline, where our pudafensine actually comes in and regulates much more than dopamine. So that also gives some huge benefits on safety and some of the side effects that are known with the first generation of monoamine modulators.
So you have shown, or not you, but the candidates have shown strong results in erectile dysfunction, both as a monotherapy and in combination with PDE5 inhibitors. `Could you just summarize some of the clinical takeaways so far?
Yeah, so we have shown monotherapy efficacy in patients, and the combination with a PDE5 inhibitor is something that's been done in preclinical animal models. So the recent study we conducted was a Phase IIb study in 130 patients of men suffering from moderate to severe erectile dysfunction. And what we showed here, we actually showed we could increase the sexual responses in these patients when they used a single dose. So the study design we did was they received four doses of it with a week in between, and then we actually looked at the responses in these patients. So this is actually for the first time shown that actually we can safely modulate the central nervous system to strengthen the erection response. And this is very unique.
People have been trying or attempting to use dopamine for multiple years to increase sexual responses, but there were always so many side effects with the drugs that they used. And we have actually done that, modulating dopamine in a safe way, and we did not see any side effects. Actually, at the effective dose levels, we could see there was no difference between the side effect profile with that of the placebo group. So very unique.
You're also exploring women's health with your candidate. What insights from your clinical work sort of supports the expansion into women's health?
Yeah, so the way we look at it, of course, when we talk about sexual health, it's not only addressed to men. So when we originally started out with an ED, erectile dysfunction for men, we actually, it's the animal models are quite good, so there's a strong translatability of what we can show in preclinical models and actually in the clinic. And that we have also demonstrated. But looking at female sexual dysfunction, or HSDD, hypoactive sexual desire disorder, is somewhat more complicated, especially because the models that you are trying to use, so the female mice you are trying to show increased blood flow to the genitals, have often been overloaded with hormones. And we know that the majority of the women in the postmenopausal phase do not have a lot of hormones.
So they're not overloaded with hormones.
So they are not good models, so we needed to find a different way. So that we have done in the lab, and we are now showing in preclinical models that we can strengthen that. From the pain perspective, we already knew when we acquired pudafensine that it had real good preclinical pain data. And that also led us to do a healthy volunteer capsaicin pain-induced study where we could show that we had real good pain relief, and especially on what's called allodynia. And by doing that, we actually started investigating what is the right indication for this, where should this fit in. And we knew that there's a lot of good pain indications out there, but we needed to find a pain indication that had a few criteria that it matched, that it would help benefit from increased dopamine. It had a pain profile that matched our compound.
It was high on medical need, and we wanted to be first in class in this indication. And looking at these, there's many pain indications, and we actually discovered, you can say, vulvodynia, which is a very unspoken pain indication. And of course, that is a women's indication, and that's how we actually came into women's health from a pain perspective.
So you started with the pain, and then you're looking into further female, yeah.
Yeah, so and you can say, so the pain will be in women's health, but we actually see that pain can be used in other indications. But we're actually pushing forward with the indication of vulvodynia because that's where there's a real strong scientific rationale. But also, there's nothing approved for these women. It's one out of ten women, so it's 17 million women in Europe, 13 million women in the U.S do not get a treatment for daily severe pain. And that is a high unmet medical need. It's a unique opportunity, and we see between one to two to three billion potential peak sales market here with pudafensine and vulvodynia.
Like you said, you are preparing for a Phase II trial in vulvodynia, and that's expected to start next year. How's that coming along? Where are you in the preparation?
Yeah, so we filed the paperwork September 3rd to the MHRA in the U.K. We are doing the clinical trial again in the U.K., and actually our ambition is to start it this year, so at the end of 2025. Now we are, you can say, we have done all the prep work. We know how the study design is going to be. I can come into that later, and then we're just waiting for the authorities. Fingers crossed, everything will go smooth through, and we will start dosing it towards the end of the year. The study we'll conduct is what we call a four-way crossover. We will bring in women that are suffering from vulvodynia, and then we will test them. They will get three doses of vulvodynia, high, low, and medium dose levels on individual visits, and also a placebo.
That way we can use themselves as their own control, and we will generate as much data we can in this Phase II setting where we give single doses and test them for pain relief in vulvodynia patients.
I can see from the questions that we'll get back to that, but I also wanted to touch on you have some other, you have quite a broad portfolio, and you have IP2018, you probably say it differently, in psychogenic erectile dysfunction, and you also have a candidate in preclinical pain. How do these programs complete the lead asset? How does this all fit together?
So the 2018 candidate, as we call it IP2018, is in what we call psychogenic ED. That's also erectile dysfunction, but it has a little bit of a different origin than what we use pudafensine for. You can publicly say that pudafensine is for us men when we turn 40 and older. We get physical impairment to deliver sufficient blood to the penile tissue, and therefore we need something that strengthens this normal erection response. When you look at psychogenic ED patients, this is what we also can talk about, mild depression or low mood. So this can often be younger men as well. And that's also the case in women, but we only have data in men. So that's people that have anxiety, performance anxiety, low self-esteem, or patients that are taking an antidepressant. We know about 80% of all patients taking antidepressants develop sexual dysfunctions.
So here, this is, you can say, it's a little bit different profile. We need still to strengthen the dopamine, but we also need to touch the serotonin. And both of the products we're talking about here are on-demand drugs. So it's an oral tablet you take on the day that you want to engage in an intercourse.
So 2018 could potentially have a role to play in depression, you think, or?
Yeah, so it has a real good depression profile. We have not tested in depression in patients. We just tested for erectile dysfunction. So for many years, we have used monoamines to modulate, you can say, depression. But as I said, a lot of these develop sexual dysfunctions because of the profile of the modulators, where we have a profile that do not induce any of these sexual dysfunctions.
Turning a little bit to the financial side of things, you have a collaboration with MAC Clinical Research. They are shareholders, and you have a financing agreement with them for partial financing of the vulvodynia study that we talked about. How do you see such partnerships supporting your clinical progress?
Yeah, we heard in the panel earlier today that it's good to have people that actually believe in what you do, and we see MAC as a truly validating investor, but also a partner. So they now invested in two clinical trials, and they actually are experts in modulating the central nervous system, conducting trials in that space. It's a private-owned organization, and the CEO, Mark Dale, looks at the assets they're doing and the clinical trial, and he has always been intrigued by the safety profile of pudafensine, that we can dose it while seeing these normal side effects, and we still see efficacy. So that has actually led to the collaboration with them. So we know that a lot of smaller biotechs like ourselves have, of course, difficulties handling big CROs.
By doing this collaboration, we actually have, you can say, we hold hands in the way that they also have an interest in completing on time. They also have an interest in making sure that the patients that we are getting into the study are actually the right patients, so we get the best possible results coming out of this. We see this as a truly validating having MAC as an investor in the company.
You recently raised SEK 48 million in a rights issue where you had fairly strong backing from your key investors. How does this funding leave your position going forward?
Yeah, so we are, of course, very grateful that Linc and MAC stepped up in the recent round, and also we had multiple of our long-term shareholders stepping up into this and making sure that we actually got the necessary capital in so we could pay for the pass-through cost of the Phase IIA trial in vulvodynia. You can say with the money we raised now, we have money running into 2027, so that means that we'll have money to after. We expect the trial to read out sometime in the latter part of 2026, if everything goes according to plan, which we believe, because we actually think we made a real good strong study design.
We have now experience in recruiting patients a lot more in the U.K., what to do, and if you go to MAC's homepage, you will see some of these new advertisements that are coming out for the patients that are going to be recruited for this study.
Turning to the questions from the audience, which markets are of special interest, or are you like, someone said before, everywhere?
Yeah, you can say, of course, that there's two big markets in our perspective, and then normally you would say there's also Asia, but we definitely know talking about vulvodynia is not something you talk so much out there. But we know that in Europe, there's 17 million women suffering from this, but the premium pricing is still the U.S., and hence there's nothing approved. We actually think that launching in both markets, of course, will make good sense. And as I said, you know, very, very conservative estimates are looking at a $1 billion potential market here in peak sales. So those are the two markets we go into.
We are, of course, looking for partners that actually can have an infrastructure for launching these products, and that is why we're now generating the data showing that actually pudafensine also has the efficacy that we believe it will have in vulvodynia, which we already saw in the healthy volunteer study, and then next step for that is finding the right partners to advance towards the market launch.
So there seems like there's potentially some work to do to raise awareness of vulvodynia as an indication as well. Is that something you're working on?
Yeah, so there's a lot of things going on. I think that there's been a campaign for endometriosis for a long time, so we all know that vulvodynia is actually more common in endometriosis. So it is something that, you know, we need to start talking more about. Also, the gynecologist, of course, knows this, and the specialist and the GPs know about this. So we need to increase awareness, and we see that slowly coming. There's more and more focus on these pain indications or indications in general where there's no good therapies out there. And also, of course, we see that in women's health, there's also a lot of attention right now.
Viagra is offered as an over-the-counter drug in the U.K. Is that regulatory route something that you could consider going down?
So I can say no almost straight away because you can say that, as I said, PDE5s are peripheral-acting compounds, and so you can say that that is somewhat easier to control. We are working on the central nervous system, so that would most likely never be over the counter. So, but you could combine it, and then it will still be something you need a prescription for. You can say Viagra or the PDE5s, they have a lot of side effects. You lose your blood pressure, drop in blood pressure, and so on. So you've got to be a little bit careful taking these. So you can say over the counter, but if you take heart medication at the same time, you could get actually some side effects that you don't want. So we actually still believe that it's the best one to prescribe the medicine is a GP.
You used to work a bit with premature ejaculation, didn't you? Is that something that you have put to one side?
No, so the premature ejaculation was a little bit some of our competitors, you can say, in the market. They had more focus on that. We know that dopamine also plays a role in premature ejaculation, but the endpoints are real difficult, and it's something that's not something we have focused on, no.
Of interest to you. More financial questions. Looking at your cash runway and the burn rate forecast, what is the financial forecast for when the Phase II trial is initiated?
The Phase II, we still expect that to start in the second half of, so in Q4 of this year.
Perfect. Could you please elaborate on the manufacture of your modality, scale-up, commercial manufacture, cost, and so on? These things are not cheap.
Yeah, so the good thing about producing a small molecule that is cheap compared to radiotherapies or to antibodies. We have a very simple three-step synthesis of our compound. We have actually done all the synthesis with a big international CRO called Syngene, based in India, and they are regularly inspected by the FDA, and they're working for multiple of the big pharma companies in the world. So we outsource all the API, and also they have made the drug product for us. So you can say it's a reasonable team. There's a high bar for whoever ends up launching this. There's a high premium on the product that we produce.
Thank you so much, Claus.
Thank you very much for hosting me. Thank you.